NCT07850492Not yet recruiting
High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
Association Between High-Sensitivity Cardiac Troponin T Kinetics, Postoperative Complications, and 30-Day Mortality in Patients With Cardiovascular Risk Undergoing Major Abdominal Surgery: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
Major abdominal surgery (MAS) carries a high risk of 30-day mortality (\>5%). Perioperative myocardial injury (PMI) and myocardial injury after noncardiac surgery (MINS) frequently develop asymptomatically due to surgical analgesia. The 2022 European Society of Cardiology (ESC) Guidelines recommend routine surveillance with high-sensitivity cardiac troponin (hs-cTn) before and after surgery in high-risk patients, defining PMI by an absolute increase in hs-cTnT \>= 14 ng/L or a peak \> 5x ULN (\> 70 ng/L). However, validation in Asian populations and major abdominal visceral resections is scarce. This prospective observational cohort study (TROP-MAS) recruits \>= 650 consecutive high-cardiovascular-risk patients undergoing major abdominal surgery at Bach Mai Hospital (Hanoi, Vietnam). The study systematically evaluates the incidence and prognostic significance of hs-cTnT kinetics (T0 baseline, T1 24h, T2 48h postoperative) regarding 30-day all-cause mortality, major adverse cardiovascular events (MACE), and severe noncardiac complications (acute kidney injury, sepsis, anastomotic leak, bowel ischemia). Furthermore, it derives and validates population-specific optimal prognostic cut-off values using ROC curve analysis and multivariable Cox modeling.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 650 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Bach Mai Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07850492
What you commit to
- Study type: Observational
- Planned participants: 650
- From 1 Oct 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active acute myocardial infarction or acute coronary syndrome within 30 days prior to the index surgical procedure.
- Intraoperative mortality or death within the first 24 hours postoperatively due to acute massive surgical exsanguination.
Other illness
- End-stage renal disease (ESRD) on maintenance hemodialysis or peritoneal dialysis.
Other
- Incomplete postoperative troponin testing protocol (missing both 24h and 48h postoperative blood samples).
- Patient or legal surrogate withdrawal of consent during the 30-day surveillance period.
Who the study is looking for
- Scheduled for or undergoing elective, urgent, or emergency major abdominal surgery (pancreatectomy, liver resection, gastrectomy, colorectal surgery, or emergency laparotomy) with expected duration \>= 2 hours or major visceral resection.
- Possessing established or potential cardiovascular risk defined by meeting AT LEAST ONE of the following:
- Age \>= 65 years; OR
- Age 45 to 64 years with at least one documented cardiovascular risk factor or comorbidity: documented coronary artery disease, congestive heart failure, prior ischemic stroke or TIA, peripheral arterial disease (resting ABI \<= 0.90), diabetes mellitus requiring treatment, arterial hypertension, dyslipidemia/hypercholesterolemia, active cigarette smoking, overweight/obesity (BMI \>= 25 kg/m\^2), family history of premature cardiovascular disease, unexplained cardiac signs/symptoms, chronic obstructive pulmonary disease (COPD), baseline chronic renal impairment (eGFR \< 60 mL/min/1.73m\^2 or serum creatinine \> 177 umol/L), or Revised Cardiac Risk Index (RCRI) \>= 2 points.
- Signed Informed Consent Form permitting electronic medical record (EMR) data extraction and participation in a 30-day follow-up telephone interview.
Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bach Mai Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.